Cleared Traditional

K121156 - AUTOMATED IN VITRO QUANTITATIVE ASSAY F...

K121156 is the FDA 510(k) clearance for AUTOMATED IN VITRO QUANTITATIVE ASSAY F... by Phadia AB. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 331-day FDA review.

K121156 · Phadia AB · Immunology device
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Mar 2013
Decision
331d
Days
Class 2
Risk

K121156 is an FDA 510(k) clearance for the AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFI.... Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Phadia AB (Portage, US). The FDA issued a Cleared decision on March 13, 2013 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5750 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Phadia AB devices

Submission Details

510(k) Number K121156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2012
Decision Date March 13, 2013
Days to Decision 331 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
227d slower than avg
Panel avg: 104d · This submission: 331d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHB System, Test, Radioallergosorbent (rast) Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DHB System, Test, Radioallergosorbent (rast) Immunological

All 188
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K121156.
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K182479 · Hycor Biomedical · Dec 2018
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IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY
K132801 · Siemens Healthcare Diagnostics, Inc. · May 2014
IMMUNOCAP ALLERGEN K82
K121463 · Thermo Fisher Scientific · Jan 2013
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K112523 · Siemens Healthcare Diagnostics, Inc. · Jan 2012
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K101572 · Siemens Healthcare Diagnostics · Aug 2011